BILL ANALYSIS Ó
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PROPOSED TO BE AMENDED
Date of Hearing: September 9, 2015
ASSEMBLY COMMITTEE ON AGRICULTURE
Henry Perea, Chair
SB
27 (Hill) - As Amended September 4, 2015
SENATE VOTE: 25-10
SUBJECT: Livestock: use of antimicrobial drugs.
SUMMARY: This bill prohibits, beginning January 1, 2018, the
use of medically important anti-microbial drugs (MIAMs) for the
treatment of livestock animals, except pursuant to a
prescription or feed directive from a licensed veterinarian and
when, in the professional judgment of a licensed veterinarian,
the MIAMs are necessary: 1) to treat a disease or infection; 2)
to control the spread of disease or infection; or 3) in relation
to surgery or a medical procedure. This bill allows for
prophylaxis to prevent the elevated risk of disease transmission
or infection and forbids the use of MIAMs for growth promotion
and feed efficiency. Specifically, this bill:
1)In order to implement and monitor compliance with the MIAM
rules, the bill requires the California Department of Food and
Agriculture (CDFA) to:
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a) Coordinate with the federal Food and Drug Administration
(FDA) to develop a program to track antimicrobial drug
sales, use, resistance, and management practices; and,
b) Develop antimicrobial stewardship guidelines on good
management practices in consultation with the Veterinary
Medical Board (VMB), the California Department of Public
Health (DPH), universities, and cooperative extensions;
and,
c) Conduct outreach and training, and report to the
Legislature by January 1, 2019, the results of outreach and
monitoring activities.
EXISTING LAW:
Federal law:
1)Requires FDA to protect public health by ensuring the safety,
effectiveness, quality, and security of human and veterinary
drugs. Within FDA, the Center for Veterinary Medicine
regulates the manufacture and distribution of drugs that will
be administered to animals and regulates medicated feed.
2)Established the Animal Drug Availability Act in 1996 to create
a new regulatory category for certain animal drugs used in
animal feed. Previously, drugs were only available through
two means: over-the-counter (OTC) and by prescription. As new
drugs (antimicrobials) were developed, FDA recognized the need
for these drugs to be administered through feed.
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3)Created the Veterinary Feed Directive (VFD) to allow more
flexibility for new animal drugs to be administered through
medicated feed, under the supervision of a licensed
veterinarian.
State law:
1) Requires CDFA, through the Livestock Drug Program, to
regulate the manufacture, sale, registration, and use of
livestock drugs, except when the livestock drug is sold by
prescription only, used exclusively by a veterinarian, or
used only under a veterinarian's direction. CDFA is
required to register OTC livestock drugs and regulate their
use for safety and efficacy.
2) Requires the California State Board of Pharmacy to
enforce laws and regulations regarding prescription drugs
and drugs used exclusively by veterinarians.
FISCAL EFFECT: According to the Assembly Appropriations
Committee, this bill has:
1)Estimated General (GF) and Special Fund (SF) costs of
approximately $864,000 in 2015-16 and $4.8 million in 2016-17
to develop programs, stewardship guidelines, monitoring
systems and procedures, and regulations, as well as begin
training, inspections, and MIAMs use tracking. Annual GF and
SF costs of approximately $4.3 million thereafter to continue
training, inspections, and tracking. Some of these costs may
be funded from federal and local sources, and potentially
offset in part with civil fine revenue.
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2)Potentially significant costs to VMB and DPH to help develop
stewardship guidelines and training materials.
COMMENTS: Antimicrobial drugs have been widely used in human
medicine since the 1940s. Antimicrobial drugs have significant
health benefits in both human and animal medicine, and are
important and valuable tools used to treat and prevent illness
and infection. Incidences of antimicrobial resistance have been
recorded over time and, if left unchecked, pose a threat to
public health.
The Centers for Disease Control (CDC) estimates that in the
United States, more than two million people are sickened every
year with antibiotic-resistant infections, with at least 23,000
infections resulting in death. CDC notes that the use of
antibiotics is the single most important factor leading to
antibiotic resistance around the world. Up to 50% of all
antibiotics prescribed for people are either not needed or not
optimally effective as prescribed. Antibiotics are also used in
food-producing animals for the purpose of promoting growth,
which CDC recommends phasing out.
The FDA has issued several industry recommendations regarding
the use of MIAMs in the feed and drinking water of
food-producing animals. The recommendations contained in
Guidance for Industry #152, #213, and #219 establish lists of
antibiotics important to human health, promote judicious use of
those drugs in food production, and encourage veterinary
oversight to ensure compliance with industry best practices.
In March 2015, President Obama issued a national action plan on
combating antibiotic-resistant bacteria. The five year action
plan articulated goals of slowing the emergence of resistant
bacteria, strengthening surveillance efforts, advancing the
development and use of rapid diagnostics to identify resistant
bacteria, accelerate development of new antibiotics, treatments,
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and vaccines, and improve collaboration among stakeholders. For
antimicrobial use in food animals, the plan seeks to implement
FDA guidance.
According to the author, overuse and misuse of antibiotics in
livestock animals, especially antibiotics important in human
medicine, contributes to antibiotic resistance. To address the
overuse and misuse, this bill is intended to ensure veterinary
oversight; encourage judicious use of MIAMS and prohibit use for
growth promotion and other nontherapeutic purposes; and, monitor
MIAM sales, usage, management practices, and resistance.
According to supporters, many antimicrobials used in food
production are currently available at feed stores and online,
without any veterinary prescription or oversight and this bill
will stop this practice along with making all use of MIAMs
require a prescription. Furthermore, supporters argue the
prophylactic use exception has been carefully crafted for
judicious use of MIAMs, and the bill explicitly forbids MIAM use
for growth promotion and feed efficiency.
Opponents argue this explicitly authorizes the routine use of
antibiotics on animals that are not sick through the exception
for prophylactic use to prevent disease transmission or
infection. Opponents fear prophylactic use will allow back door
use for nontherapeutic purposes, and is precisely the low-dose
use that contributes most to resistant bacteria. Furthermore,
opponents assert that the expanded surveillance of MIAM relies
on voluntary cooperation from participants to gather samples and
is insufficient to provide statistically significant or accurate
data on actual MIAM use and resistance.
The proposed amendments do the following:
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1) Strike a section dealing with preventive use of MIAMs
and instead allow for preventive use of MIAMs when it is
determined by a veterinarian that MIAMs are needed to
address an elevated risk of a disease or infection.
2) Clarify that CDFA has the authority to request and
receive records related to VFDs, as specified.
3) Make technical and clarifying changes.
REGISTERED SUPPORT / OPPOSITION:
Support
Adventist Health
California Academy of Preventive Medicine
California Children's Hospital Association
California Naturopathic Doctors Association
California Optometric Association
California Society of Health-System Pharmacists
California State Parent Teacher Association
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California Veterinary Medical Association
Humane Society Veterinary Medical Association
Infectious Disease Association of California
Loma Linda University Health
Opposition
Alliance for the Prudent Use of Antibiotics
Animal Welfare Approved
California League of Conservation Voters
California Public Health Association -North
CALPIRG
Center for a Livable Future, Johns Hopkins Bloomberg School of
Public Health
Center for Food Safety
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Compassion Over Killing
Consumers Union
Dignity Health
Environmental Working Group
Food & Water Watch
Food Chain Workers Alliance
Green America
Health Care Without Harm
Institute for Agriculture and Trade Policy
Natural Resources Defense Council
Organic Consumers Association
Physicians for Social Responsibility, San Francisco Bay Area
Chapter
Prevention Institute
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Roots of Change
San Francisco Baykeeper
Slow Food California
Women Organizing Resources, Knowledge and Services (WORKS)
Analysis Prepared by:Victor Francovich / AGRI. / (916)
319-2084